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    PORTICO TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code NPT·August 12, 2025

    GS 777 WALL TRANSFORMER W/OPHTH & OTO UK

    FDA Adverse Event
    Malfunction ·WELCH ALLYN INC.·Product code GCW·September 2, 2025

    767 INTEGRATED DIAGNOSTIC WALL SYSTEM

    FDA Adverse Event
    Malfunction ·WELCH ALLYN, INC.·Product code GCW·July 8, 2014

    9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code GCW·April 13, 2017

    7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code GCW·April 13, 2017

    Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number TA6035L; EXP (repackager), Covidien (OEM) Implantable Staple

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GCW·February 11, 2015

    9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code GCW·April 13, 2017

    Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number GIA8048L; EXP (repackager), Covidien (OEM) Implantable Staple

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GCW·February 11, 2015

    9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code GCW·April 13, 2017

    Transformer, Endoscope

    FDA classification
    FDA Class 2 ·Transformer, Endoscope

    GCE, s.r.o.

    FDA registration
    GCE, s.r.o.·3 products·🇨🇿 Czechia

    DCW Carson

    FDA registration
    DCW Carson·2 products·🇺🇸 United States

    GCB MEDICAL LLC

    FDA registration
    GCB MEDICAL LLC·10 products·🇺🇸 United States

    GCE INTERNATIONAL INC

    FDA registration
    GCE INTERNATIONAL INC·1 product·🇺🇸 United States

    BCW ADVANTAGE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    WHEELCHAIR BCW 6000

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MediTec

    FDA UDI
    GCE, s.r.o.·08592346749320·The regulator acts as a pressure-reducer, gas f...

    MediMeter

    FDA UDI
    GCE, s.r.o.·08592346749405·Mediflow devices are intended for the administr...

    MediFlow Ultra II

    FDA UDI
    GCE, s.r.o.·08592346892781·The regulator acts as a pressure-reducer, gas f...

    MediSelect II

    FDA UDI
    GCE, s.r.o.·08592346892668·The regulator acts as a pressure-reducer, gas f...